Eisai/Biogen’s Leqembi Gets Some Medicare Coverage Certainty In CMS Update

Unclear If Registry Requirement Will Limit Patient Access

CMS said Medicare will cover anti-amyloid antibodies for early Alzheimer’s disease upon traditional approval from the US FDA if prescribed by doctors participating in a patient registry. 

The US Centers for Medicare and Medicaid Services (CMS) has answered a big question about Eisai Co., Ltd./Biogen, Inc.’s Leqembi (lecanemab) for early Alzheimer’s disease: Will the product garner Medicare coverage if its accelerated approval converts to full approval as expected by its 6 July action date with the US Food and Drug Administration? CMS said on 1 June that Medicare Part B will cover the costs of anti-amyloid antibodies on the same day that the FDA grants traditional approval, with one caveat.

While CMS said in its statement that it wants to make sure patients with mild cognitive impairment or early dementia...

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